Galapagos NV announced that the selective JAK1 inhibitor filgotinib improved the symptoms of active rheumatoid arthritis and met key efficacy endpoints after 12 weeks of treatment. This Phase 2B study achieved its primary endpoint with a statistically significant improvement versus the placebo. These first results in the ongoing 24 week study are consistent with the efficacy/safety profile of filgotinib observed in the prior 4-week clinical studies.
DARWIN 1 is an ongoing, 24 week, double-blind, placebo-controlled evaluation of filgotinib, with as once- and twice-daily administration (QD and BID dosing) at 3 daily dose levels. Results were reported for 594 patients with moderate to severe rheumatoid arthritis who showed an inadequate response to methotrexate and who remained on their background therapy of methotrexate. These patients received filgotinib or placebo and were evaluated up to 12 weeks, the time of the primary endpoint of the study. Galapagos expects to report the full 24 week results for DARWIN 1 around the middle of the year.
